TriangleNCT00980460 · OUTCOME
Number of Deaths
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- During protocol therapy or within 30 days of the termination of protocol therapy up to 1 year after enrollment
What was measured
Number of patients who experience on-protocol-therapy death possibly, probably or likely related to systemic chemotherapy. This outcome measure applies to INTERMEDIATE RISK patients only.
Analysis population: Only eligible patients are considered in the calculation of this outcome measure.
Groups in this outcome
Intermediate-risk Group (Regimen F)
Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
| Group | Source count |
|---|---|
| Intermediate-risk Group (Regimen F) | 102 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intermediate-risk Group (Regimen F) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 102
- units
- Participants
- description
- Number of patients who experience on-protocol-therapy death possibly, probably or likely related to systemic chemotherapy. This outcome measure applies to INTERMEDIATE RISK patients only.
- groups
- description
- Patients receive C5VD chemotherapy comprising cisplatin IV over 6 hours on day 1, fluorouracil IV over 2-4 minutes on day 2, vincristine sulfate IV over 1 minute on days 2, 9, and 16, and doxorubicin hydrochloride IV over 15 minutes on days 1-2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo surgical resection after course 2 OR surgical resection or liver transplantation after course 4 of C5VD. Patients may also receive dexrazoxane IV over 5-15 minutes on days 1-2 of courses 5 and 6. (Closed to accrual as of 3/12/2012) Cisplatin: Given IV Dexrazoxane: Given IV Doxorubicin Hydrochloride: Given IV Fluorouracil: Given IV Laboratory Biomarker Analysis: Correlative studies Liver Transplantation: Undergo liver transplant Therapeutic Conventional Surgery: Undergo surgery Vincristine Sulfate: Given IV
- id
- OG000
- title
- Intermediate-risk Group (Regimen F)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only eligible patients are considered in the calculation of this outcome measure.
- reporting Status
- POSTED
- time Frame
- During protocol therapy or within 30 days of the termination of protocol therapy up to 1 year after enrollment
- title
- Number of Deaths
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice